Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas

Skin Burn Clinical Trial

Official title:

Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05996614
• Other study ID #: PRP in skin grafts
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: Assiut University
• Contact: Ibrahim Ragab Ibrahim, master
• Phone: 00201060865454
• Email: himo_nimo9[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. To evaluate the effect of the platelet rich plasma on the take of split thickness skin graft and its early and late results in resurfacing of post burn raw areas.

2. To evaluate the effect of PRP on wound healing on skin graft donor site.

Description:

Burn injuries involve tissue destruction due to energy transfer,The burn injuries can be caused by heat from hot liquids, solids or fire, an less common causes are friction, heat, chemical or electric sources The treatment of burns is complex due to the combination of hypermetabolic physiological response and the need for good functional and cosmetic recovery. Split thickness skin grafts (STSGs) are commonly used to resurface large areas of Post burn raw areas.

The time to complete wound healing ranged from 2 to 75 days. Factors that significantly affected time to complete wound healing were graft loss by seroma, presence of hypergranulation tissue, premorbid conditions, and total body surface area burned.

Generally, skin graft undertakes three steps for healing: anchorage, inosculation, and maturation. Haematoma, shearing, and infection on recipient sites of skin graft can reduce skin graft take, and even lead to skin graft loss.

Platelet-rich plasma (PRP) is an autologous blood-derived biomaterial that is enriched with a 2- to 6-fold concentration of platelets in comparison to normal human platelet concentration. Multiple growth factors and bioactive proteins are stored in α-granules of platelets. These growth factors can promote proliferation of endothelial cells, epithelial cells as well as fibroblasts, and increase angiogenesis. The potential clinical application of PRP in skin graft might rely on its haemostasis, adhesive, antibacterial and healing properties.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age (15- 60 years).

2. Post burn Raw area less than 10 % of total body surface area .

3. Selected donor sites.

Exclusion Criteria:

1. Raw area due to other causes ( trauma, ischemia,..etc)

2. Patients with bleeding tendency.

3. Patients with comorbidities(diabetes, malignancy,..etc)

Related Conditions & MeSH terms

• Burns
• Skin Burn

Intervention

Procedure:
• PRP in skin grafts
topical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas
• conventional methods in skin grafts
fixation of the graft with stitches and staplers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Garcia-Sanchez JM, Mirabet Lis V, Ruiz-Valls A, Perez-Plaza A, Sepulveda Sanchis P, Perez-Del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histopathological biopsy from both groups by punch Biopsy (vancouver scale )	pigmentation (0-2) ,normal 0, Hypopigmentation 1 ,Hyperpigmentation 2 Vascularity (0-3) ,Normal 0, Pink 1, Red 2, Purple 3 Pliability (0-5) Normal 0 ,Supple 1 ,Yielding 2,Firm 3, Banding 4, Contracture 5 Height (0-3) Normal(flat)0 ,(0-2mm)1,(2-5mm)2,(>5mm)3	3 months